This trial is active, not recruiting.

Condition peanut allergy
Treatment peanut protein capsule
Phase phase 2
Sponsor Aimmune Therapeutics, Inc.
Start date August 2014
End date July 2016
Trial size 53 participants
Trial identifier NCT02198664, ARC002


This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Biological: Capsules containing peanut flour, oral immunotherapy, will be used for dose escalation build-up, and maintenance phase
peanut protein capsule
characterized peanut allergen provided in break apart capsules for oral immunotherapy

Primary Outcomes

The incidence of treatment-related adverse events and dosing symptoms occurring with peanut OIT over a protracted treatment period comprising at least 18 months
time frame: Up to 90 weeks

Eligibility Criteria

Male or female participants from 4 years up to 26 years old.

Inclusion Criteria: - Completion of ARC001 study - Use of birth control for females of child-bearing age - No change in the status of any longitudinally applicable ARC001 inclusion criteria Exclusion Criteria: - Early termination from ARC001 - Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge - A lapse in dosing of more than 10 days from completion of ARC001 - Change in the status of any longitudinally applicable ARC001 exclusion criteria

Additional Information

Official title Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
Description All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA). Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Aimmune Therapeutics, Inc..